Gleize

Researchers are evaluating the safety and effectiveness of a new combination treatment using BMS-986489 (a fixed dose combination of BMS-986012 and Nivolumab) alongside Carboplatin and Etoposide compared to the current standard treatment with Atezolizumab plus Carboplatin and Etoposide. This study focuses on adults with extensive-stage small cell lung cancer and is conducted as a phase 3 randomized, double-blind, multicenter trial. The goal is to find out which combination works better as a first-line therapy for this advanced lung cancer. Participants will receive either BMS-986489 combined with Carboplatin and Etoposide or Atezolizumab combined with Carboplatin and Etoposide. Each drug will be given at specified doses on certain days according to the study protocol. The study compares these two treatment approaches to see their effects and safety when used as initial therapy for extensive-stage small cell lung cancer. During the study, participants will be closely monitored over a period of up to 5 years to assess overall survival. Researchers will use imaging techniques like CT scans or MRIs to measure tumor response and will evaluate participants' health and ability to perform normal activities. Safety and side effects will also be tracked throughout the study to ensure participant well-being.

Researchers are evaluating the effectiveness and safety of lorlatinib in patients with untreated ALK-positive non-small-cell lung carcinoma (NSCLC) in a real-world French context. The study focuses on adults aged 18 years or older who have locally advanced or metastatic ALK-positive NSCLC confirmed by specific diagnostic methods. This non-interventional study aims to understand how lorlatinib performs outside of controlled clinical trial settings. Participants will receive lorlatinib as the treatment for ALK-positive NSCLC. Before starting treatment, patients must undergo a complete radiological assessment including contrast-enhanced CT scans of the thorax and upper abdomen and brain MRI, as per routine care. The study monitors patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, reflecting their ability to carry out daily activities. During the study, researchers will assess progression-free survival from the start of treatment up to 25 months. Patients will be followed through scheduled visits and examinations, including evaluations of clinical status and safety monitoring. Participants are expected to comply with the study protocol throughout the observation period, and data will be collected according to standard care practices in a real-world setting.

Palpitations are a common reason for emergency and cardiology consultations, but diagnosing their cause can be challenging because symptoms are often transient and not present during medical evaluation. The usual diagnostic approach involves a 48-hour ECG Holter monitor, sometimes combined with a stress test if symptoms occur during physical activity. This trial is investigating whether using a connected watch ECG can provide a more cost-effective and efficient way to detect arrhythmias compared to the traditional Holter monitor over six months. Participants will receive a connected watch along with instructions and support to use the Health Mate application on their personal smartphone or tablet. They can transmit up to three ECG recordings during symptomatic episodes. A follow-up phone call at two months will check their understanding, device use, any adverse events, and compliance. The study compares the diagnostic yield of the connected watch ECG with the conventional 48-hour Holter ECG. Throughout the study, researchers will monitor and evaluate whether a diagnosis of arrhythmia is made within six months or if three symptom-related ECG transmissions show no arrhythmia. Participants will be assessed based on the rate of diagnostic success between the two methods. The study includes ongoing support and safety monitoring, with participants required to wear the watch continuously except during charging and to have compatible devices and internet access for data transmission.

Researchers are evaluating a patient-centered clinical decision support system called "Lianeli" in primary care. The system helps primary care professionals identify patients eligible for recommended health screenings based on guidelines from the French National Authority for Health. This study aims to improve shared decision-making between doctors and patients during prevention-focused consultations, addressing common barriers like lack of patient information and limited time for doctors. The Lianeli system involves patients completing a health questionnaire first, then using the tool together with their general practitioner during a dedicated prevention consultation. The study also includes individual interviews and focus groups with patients and primary care professionals to assess the system's feasibility based on factors like usability, content, and implementation quality. Participants will be monitored to see if they fully use the Lianeli system within 60 days after their initial consultation. Researchers will conduct qualitative interviews one month after follow-up to understand user experience and feasibility. The study includes adults aged 18 to 74 who visit their general practitioner and can communicate in French, with follow-up lasting at least two months from inclusion.

Type I interferonopathies are rare genetic autoinflammatory disorders that mainly begin in childhood but can also start in adulthood. These diseases cause significant health problems and are resistant to standard immunosuppressive treatments. They primarily affect the central nervous system and often involve joints, with occasional blood-related issues like low blood cell counts or weakened immune function. Researchers aim to understand how these diseases progress over time in both children and adults to help identify markers for diagnosis and prognosis and to better characterize the variety of interferonopathies. This research focuses on tracking the natural history of type I interferonopathies in patients confirmed by genetic testing. The goal is to gather detailed information about disease evolution to uncover underlying mechanisms and find biomarkers related to disease activity. Ultimately, the study seeks to classify patient subgroups and develop personalized treatment options that can improve future clinical trials. Participants will be followed over a long period from 2025 to 2045 to monitor disease progression. The main outcome measure is the characterization of how type I interferonopathies develop in pediatric and adult patients. Throughout the study, data will be collected to better understand the clinical course, helping researchers propose targeted therapies and improve patient care in the future.

Researchers are evaluating treatments for frail patients with advanced, recurrent, or metastatic adenocarcinoma of the stomach, esophagus, or gastroesophageal junction that do not overexpress HER2. This randomized Phase II trial compares two chemotherapy combinations: Trifluridine/Tipiracil plus Oxaliplatin with or without Nivolumab, versus the FOLFOX regimen with or without Nivolumab. The study aims to assess progression-free survival over up to five years from randomization. The treatments include Trifluridine/Tipiracil given in 14-day cycles with doses twice daily for 5 days followed by 9 days of rest, and Oxaliplatin administered intravenously every two weeks with a gradual dose increase during the first eight cycles. In the FOLFOX group, patients receive Folinic Acid, Oxaliplatin, and 5-fluorouracil in a two-week cycle. Nivolumab infusions occur every two weeks for up to two years or until disease progression or intolerable toxicity. After eight cycles or if neuropathy occurs, Oxaliplatin is stopped, and the other drugs continue alone until progression or intolerance. Participants will be monitored through evaluations of tumor lesions, organ function, and adverse effects. Outcome measures focus on time without disease progression or death. Safety monitoring includes regular blood tests and assessments of side effects. Participants provide consent and must be available for treatment and follow-up during the study duration, which may extend up to five years. Archived tumor samples will be collected for additional research purposes.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.